NCT00891826已完成不适用
Omega-3 Fatty Acids in Bipolar Patients With a Low Omega-3 Index and Reduced Heart Rate Variability: the "BIPO-3" Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- SDNN (msec)
研究概览
简要总结
This study sets out to test the hypothesis that parameters of heart rate variability, as a non-invasive measure of cardiovascular risk, can be improved by the addition of omega-3 fatty acids in euthymic bipolar patients with a low omega-3 index and reduced heart rate variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the DSM-IV criteria for bipolar disorders, in remission
- •Age: 18 - 65 years
- •Low omega-3 index (<5%)
- •SDNN < 60 msec
- •Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews and fill out the Beck Depression Inventory
- •Stable psychotropic medication for at least 2 weeks
- •Subjects must be able to give written informed consent
排除标准
- •Subjects for whom the intake of omega-3 fatty acids is indicated according to recent treatment guidelines
- •Patients on Warfarin
- •Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction, stroke, embolism
- •Subjects with significant medical comorbidity
- •Pregnant subjects - due to any possible teratogenic effects of EPAX 6015 TG and corn oil, respectively, on the fetus - and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded
- •Subjects who, in the investigator's judgement, pose a current significant suicidal or homicidal risk or patients who will not likely be able to comply with the study protocol
- •Subjects fulfilling the DSM-IV diagnostic criteria for current substance abuse
结局指标
主要结局
SDNN (msec)
时间窗: at baseline and after 12 weeks
次要结局
- LF/HF ratio(at baseline and after 12 weeks)
- Time to new episode(study period (12 weeks))
- Mood Rating Scales(at baseline and after 12 weeks)
研究者
W. Emanuel Severus
M.D.
University Hospital Dresden
研究点 (2)
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